This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recently publishing new or revised guidances on nitrosamines.
A recently completed pilot project in Vietnam to validate and implement monitoring procedures for nitrosamine impurities in medicines is an inspiring example of how international collaboration and cooperation can help ensure medicines quality across geographies and strengthen the supply chain.
Nitrosamines are naturally occurring chemical compounds that people are regularly exposed to at low levels.
USP has launched the newest tool in our suite of solutions to address the evolving nitrosamines crisis: the Nitrosamines Analytical Hub, a public, web-based repository of downloadable analytical procedures to test for nitrosamine impurities and related substances in pharmaceuticals.
Revised on: January 17, 2023
In simple terms, risk is the possibility of something bad happening. It’s the uncertainty around the consequences of an activity with respect to something that we value.